METROGEL

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Cleanse treated areas before the application of METROGEL. Apply and rub in a thin film of METROGEL once daily to affected area(s). Cosmetics may be applied after the application of METROGEL. For topical use only, not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Gel, 1%. METROGEL is a clear, colorless to pale yellow gel. Each gram of METROGEL contains 10 mg (1%) of metronidazole.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

METROGEL is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following clinically significant adverse reactions are described elsewhere in the labeling: Neurologic Disease [ see Warnings and Precautions ( 5.1 ) ] Contact Dermatitis [ see Warnings and Precautions ( 5.3 ) ] Eye Irritation [ see Warnings and Precautions ( 5.4 ) ]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when prescribing for patients who are receiving anticoagulant treatment.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

11 DESCRIPTION

DESCRIPTION SECTION

METROGEL (metronidazole) topical gel, 1% is a nitroimidazole for topical use. METROGEL is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole is 2-methyl-5-nitro-1 Himidazole- 1-ethanol. The molecular formula for metronidazole is C6H9N3O3. It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds. The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with METROGEL or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 (“moderate”) on the 5-point Investigator Global Assessment (IGA) scale, with 8 to 50 inflammatory lesions and no more than two nodules at baseline. The co-primary efficacy endpoints were the percent reduction in inflammatory lesion counts and percentage of subjects with success on IGA, defined as an IGA score of 0 (“clear”) or 1 ( “almost clear”) at Week 10. The efficacy results are shown in the following table: Table 3: Inflammatory Lesion Counts and Global Scores in Subjects with Rosacea at Week 10 in a Clinical Trial METROGEL Vehicle N Results N (%) N Results N (%) Inflammatory lesions 557 189 Baseline, mean count 18.3 18.4 Week-10, mean count 8.9 12.8 Reduction 9.4 (50.7) 5.6 (32.6) Investigator Global Assessment 557 189 Subject clear or almost clear 214 (38.42) 52 (27.51) Subject with no change 159 (28.5) 77 (40.7) Subjects treated with METROGEL experienced a mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to a reduction of 5.6 for those treated with vehicle, or a difference in means of 3.8 lesions.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

How Supplied METROGEL®is clear, colorless to pale yellow in color, and supplied as follows: 60 gram tube – NDC 0299-3820-60 Storage and Handling Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Use as directed. Avoid contact with the eyes [ see Warnings and Precautions ( 5.4) ]. Cleanse treated areas before the application of METROGEL [ see Dosage and Administration ( 2 ) ] Advise patients to report any adverse reaction to their healthcare providers. Neurologic Disease Advise patients to immediately report any abnormal neurologic signs to their healthcare provider [ see Warnings and Precautions ( 5.1 ) ]. Lactation Advise women not to breastfeed during treatment with METROGEL [ see Use in Specific Populations ( 8.2 ) ]. Rx Only US Patent No. 6,881,726 and 7,348,317 Marketed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA P5XXXX-X Made in Canada All trademarks are the property of their respective owners.

PATIENT INFORMATION

PATIENT MEDICATION INFORMATION SECTION

METROGEL® (MET-TRO-GEL) (metronidazole) Gel Important: METROGEL is for use on the skin only (topical use). Do not use METROGEL in your mouth, eyes, or vagina. What is METROGEL? METROGEL is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if METROGEL is safe and effective in children. Do not use METROGEL if you are allergic to metronidazole or any of the ingredients in METROGEL. See the end of this leaflet for a complete list of ingredients in METROGEL. Before using METROGEL, tell your healthcare provider about all your medical conditions, including if you: have tingling or numbness in your hands or feet have or have had a blood disorder or disease are pregnant or plan to become pregnant. It is not known if METROGEL will harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if METROGEL passes into your breast milk. Do not breastfeed during treatment with METROGEL. Talk to your healthcare provider about the best way to feed your baby during treatment with METROGEL. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use METROGEL? Use METROGEL exactly as your healthcare provider tells you to. Cleanse the treated area before applying METROGEL. Apply and rub in a thin film of METROGEL 1 time a day to the affected area(s). You can apply cosmetics after applying METROGEL. Avoid contact of METROGEL with your eyes. What are the possible side effects of METROGEL? METROGEL may cause serious side effects, including: Peripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with METROGEL. Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with METROGEL. Eye irritation. Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with METROGEL. The most common side effects of METROGEL include: sore throat and nasal congestion upper respiratory tract infections headache Tell your healthcare provider if you get any side effects during treatment with METROGEL. These are not all of the possible side effects of METROGEL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137. How should I store METROGEL? Store METROGEL at room temperature between 68°F to 77°F (20°C to 25°C). Keep METROGEL and all medicines out of the reach of children. General information about the safe and effective use of METROGEL. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use METROGEL for a condition for which it was not prescribed. Do not give METROGEL to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about METROGEL that is written for health professionals. What are the ingredients in METROGEL? Active ingredient: metronidazole Inactive ingredients : betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water Marketed by: Galderma Laboratories, Dallas, Texas 75201 USA P5XXXX-X Made in Canada US Patent No. 6,881,726 and 7,348,317 For more information, call 1-866-735-4137. This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 11/2023

PACKAGE LABEL - 60g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

metrogel 1% (metronidazole) Gel 1% For topical use only NDC 0299-3820-60 Rx Only NET WT. 60 g For topical use only. Not for oral, ophthalmic or intravaginal use. Store at controlled room temperature, 68° to 77°F (20° - 25°C), excursions permitted between 59° to 86°F (15° - 30°C). Keep out of reach of children. Usual dosage: Apply a thin film once a day to the affected areas. See package insert for complete prescribing instructions. Each gram contains: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparben, and purified water. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, TX 76177 USA All trademarks are the property of their respective owners. Made in Canada. P50741-6